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07/11/2022

Perrigo’s HRA Pharma submits FDA application for OTC birth control

An application was submitted for an RX-to-OTC switch for Opill, a progestin-only daily birth control pill, which is also referred to as a mini pill or non-estrogen pill.
Gisselle Gaitan
Online Editor
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Perrigo’s HRA Pharma is looking to make birth control pills easier to obtain.

The company announced the submission of its application to the U.S. Food and Drug Administration for its first-ever over-the-counter birth control pill.

An application was submitted for an RX-to-OTC switch for Opill, a progestin-only daily birth control pill, which is also referred to as a mini pill or non-estrogen pill.

[Read more: Camber intros generic Yasmin]

If approved, this would be the first daily birth control pill available without a prescription in the United States, the company said.

“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.,” said Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma. “More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”

Opill consists of 0.075 mg of norgestrel and has been used to prevent pregnancy in women in the United States since it was approved in 1973, the company said.

[Read more: Blink Health debuts telemedicine offering for birth control]

Several organizations are already applauding this move, including the CHPA.

“CHPA is pleased to see the Rx-to-OTC switch pathway being used to broaden access to oral contraception. CHPA is committed to empowering self-care. If approved based on the safety and other scientific data provided by the sponsor, this switch will help ensure all Americans have greater access to basic and essential healthcare products,” said Scott Melville, CHPA’s president and CEO.

“According to survey results released this month by Data for Progress, an overwhelming majority of adults across the U.S. consider birth control to be a basic and essential part of women’s health care. Providing OTC access to daily oral contraception is a long-sought objective for women’s health advocates, care providers, and policymakers that is also supported by more than 70% of voters in the U.S.,” he said.

[Read more: Mayne Pharma, Mithra Pharmaceuticals debut Nextstellis]

“Rx-to-OTC switches have had a tremendously positive impact on U.S. healthcare over many decades by increasing consumer access to safe, effective and less expensive treatment options,” Melville said. “With more than 120 ingredients, indications or dosages making the switch from Rx to OTC status since 1976, eight occurring within the past five years, CHPA hopes to see even more applications for switch before the FDA,” Melville said. 

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